CLASS II Device recall · Reported 12 May 2021 · FDA Enforcement Report
LeverEdge Contrast Injector: 35 cc syringe recalled by LeMaitre Vascular
LeMaitre Vascular is recalling LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock, distributed nationwide in the US. The recall was initiated on 6 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1529-2021
- FDA event ID
- 87689
- Recalling firm
- LeMaitre Vascular, Burlington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2021
- FDA classified
- 4 May 2021
- Reported
- 12 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Syringes & Needles
Timeline
| 6 Apr 2021 | Recall initiated by company | |
| 4 May 2021 | Classified by FDA | +28 days |
| 12 May 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Product as listed by the FDA
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.
Nationwide AlabamaCaliforniaFloridaIllinoisIndianaKentuckyMassachusettsMissouriNew YorkOhioTennesseeTexas
Questions about this recall
Why was it recalled?
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Which lots are affected?
Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LeMaitre Vascular
All 70| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artegraft Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | Nationwide |
| Device | CLASS II | Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | AR |
| Device | CLASS II | Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Labeling Errors | NJ |
| Device | CLASS II | Artegraft Collagen Vascular Grafts recalled by LeMaitre Vascular | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Pruitt Irrigation Occlusion Catheter recalled by LeMaitre Vascular | LeMaitre Vascular | Sterility | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |